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Efficacy Study of PDE-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon

Primary Purpose

Raynaud Phenomenon

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Udenafil or Amlodipine

About this trial

This is an interventional treatment trial for Raynaud Phenomenon focused on measuring Pathological Conditions, Signs and Symptoms, Blood circulation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

secondary Raynaud's phenomenon

Exclusion Criteria:

primary raynaud phenomenon
active infection
hypersensitivity to PDE5 inhibitor or Calcium Chanel Blocker (CCB)
elevated AST/ALT (3 times above the upper normal limit)
severe renal failure
patients on nitrite or nitric oxide (NO) donor treatment
recent history of cerebrovascular accidents, acute myocardial infarction, or coronary artery bypass surgery
hypotension (less than 90/50 mmHg) or uncontrolled hypertension

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Amlodipine-Udenafil (AU) arm

Udenafil-Amlodipine (UA) arm

Arm Description

Amlodipine 10mg PO QD for 4 weeks, washout period, then Udenafil 100mg PO QD for 4 weeks

Udenafil 100mg PO QD for 4 weeks, washout period, then Amlodipine 10mg PO QD for 4 weeks

Outcomes

Primary Outcome Measures

RP Attacks Per Day

Change in RP frequency after amlodipine and udenafil number of RP attack per day 0 -- unlimited.

Secondary Outcome Measures

Change in Raynaud's Condition Score (RCS)

change in the RCS. RCS combines daily activty, frequency, duration and severity as well as impact of RP attack (Measuring disease activity and functional status in patients with scleroderma and Raynaud's phenomenon, Merkel et al,Arthritis Rheum. 2002 Sep;46(9):2410-20). Range 0-10 ordinal scale 0..good 10.. bad

Change in the RP Duration

Change in the average RP duration in minutes (min) per attack. 0 -- unlimited

Change in Health Assessment Questionnaire (HAQ)

Ordinal scale 0-10 0 good 10 bad

Change in Physician's Global Assessment on Visual Analogue Scale (VAS)

Physician's global assessment (PGA) on VAS assesses the overall condition of the patient. The scale ranges from 0 - 10, with 0 being good and 10 bad. As such, change in the GPA measures the change in the patient's condition from the baseline. negative value (decrease in value) means improvement.

Change in Digital Ulcer Number

0 - unlimited. Number of digital ulcers in all fingers are counted by the investigators and recorded at each visit. The number of ulcers in all fingers indirectly reflect the extent of critical ischemia. As such. the decrease in digital ulcer number reflects positive response to treatment (=better blood flow), whereas the increase ulcer numbers indicates worsening finger ischemia from baseline.

Change in Peak Systolic Flow (cm/Sec)

Change in digital artery flow velocity in proper palmar digital artery in cm/sec. 0-unlimited

Time-averaged Peak Velocity (cm/Sec)

changes in the averaged blood flow (Time-averaged peak velocity) Blood flow in cm/sec 0 - unlimited.

Dorsal-digital-difference.

The temperature difference between finger tips and dorsum of same hand. range 0 - unlimited in degree celcius.

Full Information

NCT ID

NCT01280266

First Posted

January 14, 2011

Last Updated

December 7, 2012

Sponsor

Seoul National University Hospital

Collaborators

Dong-A Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01280266

Brief Title

Efficacy Study of PDE-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon

Official Title

Comparison of Phosphodiesterase-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon, Double Blind, Randomized, Cross-over Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

Collaborators

Dong-A Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

Brief Summary

The prevalence of Raynaud phenomenon (RP), a reversible vaso-constriction with skin discoloration, is 5-10% in general population. Often conventional measures such as warming up or minimizing exposure to cold are not enough and many patients require treatment with a vasodilator therapy. A recent study showed a good efficacy and safety profile of sildenafil, a selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) in RP. Here, the investigators aim to examine the efficacy and safety of Udenafil, a newer PDE5 inhibitor, as compared to amlodipine, a well known calcium channel blocker, in the treatment of secondary RP in Korean patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Raynaud Phenomenon

Keywords

Pathological Conditions, Signs and Symptoms, Blood circulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Amlodipine-Udenafil (AU) arm

Arm Type

Experimental

Arm Description

Amlodipine 10mg PO QD for 4 weeks, washout period, then Udenafil 100mg PO QD for 4 weeks

Arm Title

Udenafil-Amlodipine (UA) arm

Arm Type

Experimental

Arm Description

Udenafil 100mg PO QD for 4 weeks, washout period, then Amlodipine 10mg PO QD for 4 weeks

Intervention Type

Drug

Intervention Name(s)

Udenafil or Amlodipine

Intervention Description

Amlodipine 10mg daily then Udenafil 100 mg daily OR Udenafil 100 mg daily then Amlodipine 10mg daily

Primary Outcome Measure Information:

Title

RP Attacks Per Day

Description

Change in RP frequency after amlodipine and udenafil number of RP attack per day 0 -- unlimited.

Time Frame

baselin and 4 weeks

Secondary Outcome Measure Information:

Title

Change in Raynaud's Condition Score (RCS)

Description

Time Frame

baseline and 4 weeks

Title

Change in the RP Duration

Description

Change in the average RP duration in minutes (min) per attack. 0 -- unlimited

Time Frame

baseline and 4 weeks

Title

Change in Health Assessment Questionnaire (HAQ)

Description

Ordinal scale 0-10 0 good 10 bad

Time Frame

0 and 4 weeks

Title

Change in Physician's Global Assessment on Visual Analogue Scale (VAS)

Description

Time Frame

at 0 (baseline) and 4 weeks (after treatment)

Title

Change in Digital Ulcer Number

Description

Time Frame

baseline and 4 weeks

Title

Change in Peak Systolic Flow (cm/Sec)

Description

Change in digital artery flow velocity in proper palmar digital artery in cm/sec. 0-unlimited

Time Frame

baseline and 4 weeks

Title

Time-averaged Peak Velocity (cm/Sec)

Description

changes in the averaged blood flow (Time-averaged peak velocity) Blood flow in cm/sec 0 - unlimited.

Time Frame

baseline and 4 weeks

Title

Dorsal-digital-difference.

Description

The temperature difference between finger tips and dorsum of same hand. range 0 - unlimited in degree celcius.

Time Frame

baseline and 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: secondary Raynaud's phenomenon Exclusion Criteria: primary raynaud phenomenon active infection hypersensitivity to PDE5 inhibitor or Calcium Chanel Blocker (CCB) elevated AST/ALT (3 times above the upper normal limit) severe renal failure patients on nitrite or nitric oxide (NO) donor treatment recent history of cerebrovascular accidents, acute myocardial infarction, or coronary artery bypass surgery hypotension (less than 90/50 mmHg) or uncontrolled hypertension

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eun Bong Lee, MD PhD

Organizational Affiliation

professor of Seoul National University College of Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Eun Young Lee, MD PhD

Organizational Affiliation

Assistant professor, Seoul National University College of Medicine

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Jin Kyun Park, MD

Organizational Affiliation

Seoul National University Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

24352340

Citation

Lee EY, Park JK, Lee W, Kim YK, Park CS, Giles JT, Park JW, Shin K, Lee JS, Song YW, Lee EB. Head-to-head comparison of udenafil vs amlodipine in the treatment of secondary Raynaud's phenomenon: a double-blind, randomized, cross-over study. Rheumatology (Oxford). 2014 Apr;53(4):658-64. doi: 10.1093/rheumatology/ket417. Epub 2013 Dec 17.

Results Reference

derived

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Efficacy Study of PDE-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon

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